The effects of open label alpha1-antitrypsin on the progression of type 1 diabetes in subjects with detectable c-peptide
Principal Investigator: Peter Gottlieb, MD
COMIRB # 09-0667
The AAT Study
The drug Alpha-1 Antitrypsin (AAT, Aralast NP), which is being tested in this clinical trial, is an anti-inflammatory drug that affects the cells that are thought to be involved in the development of type 1 diabetes. This trial is designed to investigate the effect of intravenous AAT on preserving beta cell function and to determine if AAT will help slow the progression of type 1 diabetes.
Who can participate?
• Diagnosis of Type 1 Diabetes Mellitus based on ADA Criteria for fewer than 5 years but more than 100 days.
• 6-46 years of age.
• Positive for antibodies to insulin
• Agree to intensive management of diabetes with an HgbA1c goal of < 7.0%
What will happen in this study?
• You will be assessed for general health and diabetes care
• Eligible subjects will be treated once a week for 8 weeks (8 total treatments) with study drug administered by infusion.
• Typically, these infusions will last under 1 hour. Infusions will take place at the outpatient CTRC. All subjects will receive study drug, this is an open label trial.
Who should I call with questions or to schedule an appointment?
Lisa Meyers: 303-724-6732 or Lisa.Meyers@ucdenver.edu
Dominic DiDomenico: 303-724-5687 or Dominic.DiDomenico@ucdenver.edu